Draft EU rules on clinical trials of new medicines were endorsed by the Public Health Committee on Wednesday. A regulation designed to encourage research whilst protecting patients' rights is to replace an existing directive with simpler, more uniform rules. The new text makes specific provision for low-risk trials, clarifies the duties of ethics committees and details how to obtain informed consent from patients.
"Clinical trials are essential for developing new medicines. However, Between 2007 and 2011, the number of clinical trials started in Europe fell by 25%. Much criticism has been directed at the existing directive, which is widely believed to have led to an increase in unnecessary bureaucracy", said Glenis Willmott (S&D, UK) who is steering the legislation through Parliament.
"The aims of the Directive were admirable, but many of the requirements were geared towards trials sponsored by pharmaceutical companies, while those with non-commercial sponsors were overlooked, and true harmonisation was never achieved. Getting better legislation in place soon is crucial to enable and encourage life-saving research" she added.
The new law features simplified reporting procedures, and empowers the European Commission to do checks. Once a clinical trial sponsor has submitted an application dossier to a member state, the member state would have to respond within fixed deadlines.
MEPs amended the draft to improve transparency, by requiring that detailed summaries be published in a publicly accessible EU database, with full Clinical Study Reports published once a decision on authorisation is complete. Fines would be imposed on sponsors who do not comply with these requirements.
For low-risk clinical trials, compensation for damages would be covered by the general compensation system established under the national security or health care system. For other clinical trials, the sponsor would be deemed liable for damages, but could make use of a national indemnification system which all Member States should set up to reduce high insurance costs.
Ethics committees and informed consent
MEPs also clarified the role of ethics committees in authorising a clinical trial. Rules on obtaining a person's informed consent to taking part in a trial are laid down in detail, so as to ensure proper access to information and compensation for damages. Specific rules would also apply to clinical trials on pregnant or breastfeeding women, on persons deprived of liberty and on people with specific needs.
The report drafted by Glenis Willmott (S&D, UK) was adopted unanimously. Ms Willmott received a mandate to negotiate an agreement with EU ministers.
In the chair: Matthias Groote (S&D, DE)